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Extina

Last reviewed on RxList: 3/24/2016
Extina Side Effects Center

Last reviewed on RxList 3/5/2016

Extina (ketoconazole foam, 2%) is a topical (for the skin) antifungal medication used to treat fungal infections of the skin such as athlete's foot, jock itch, ringworm, and seborrhea (dry, flaking skin). Extina is available in generic form. Common side effects of Extina include burning or irritation at the application site, skin itching, dry skin, or headache.

The recommended dose of Extina Foam is to apply to the affected area(s) twice daily for four weeks. Other drugs may interact with Extina. Tell your doctor all medications and supplements you use. During pregnancy, Extina should be used only when prescribed. It is unknown if this drug passes into breast milk when applied to the skin. Consult your doctor before breastfeeding.

Our Extina (ketoconazole foam, 2%) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Extina Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ketoconazole topical and call your doctor at once if you have a serious side effect such as:

  • severe itching, burning, or irritation where the medicine is applied;
  • oily or dry scalp, mild hair loss;
  • redness, pain, or oozing of treated skin areas; or
  • eye redness, swelling, or irritation.

Less serious side effects include:

  • mild skin itching or irritation;
  • dry skin; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Extina (Ketoconazole Foam, 2%)

Extina Professional Information

SIDE EFFECTS

Adverse Reactions In Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be direct�ly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and for approximating rates.

The safety data presented in Table 1 (below) reflect exposure to EXTINA® Foam in 672 subjects, 12 years and older with seborrheic dermatitis. Subjects applied EXTINA® Foam or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. Adverse reactions occurring in > 1% of subjects are presented in Table 1.

Table 1: Adverse Reactions Reported by > 1% Subjects in Clinical Trials

Adverse Reactions EXTINA® Foam
N = 672
n (%)
Vehicle Foam
N = 497
n (%)
Subjects with an Adverse Reaction 188 (28%) 122 (25%)
Application site burning 67 (10%) 49 (10%)
Application site reaction 41 (6%) 24 (5%)

Application site reactions that were reported in < 1% of subjects were dry�ness, erythema, irritation, paresthesia, pruritus, rash and warmth.

Dermal Safety Studies

In a photoallergenicity study, 9 of 53 subjects (17%) had reactions dur�ing the challenge period at both the irradiated and non-irradiated sites treated with EXTINA® Foam. EXTINA® Foam may cause contact sensitization.

Read the entire FDA prescribing information for Extina (Ketoconazole Foam, 2%)

Related Resources for Extina

Read the Extina User Reviews »

© Extina Patient Information is supplied by Cerner Multum, Inc. and Extina Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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